The Effect of use Augmented Virtual Reality on Pain, Stress, Anxiety, and Self-Efficacy among Adult Cancer Patients undergoing Chemotherapy in the West Bank

Last registered on October 04, 2023
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Pre-Trial

Trial Information

General Information

Title
The Effect of use Augmented Virtual Reality on Pain, Stress, Anxiety, and Self-Efficacy among Adult Cancer Patients undergoing Chemotherapy in the West Bank
RCT ID
AEARCTR-0012172
Initial registration date
September 24, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 04, 2023, 1:47 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Palestine, State of
Region
north

Primary Investigator

Name
farid abuliel
Affiliation
Arab American University
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
On going
Start date
2023-07-01
End date
2023-12-15
Keywords
Behavior, Other, Welfare
Additional Keywords
psychological, emotional
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Background: Cancer is a serious illness that leads patients to be involved in emotional and psychological distress (Linden et al., 2012). Cancer management can have a significant impact on a patient's daily functioning and quality of life, leading to added stress and further deterioration in their mental health (Rhoten et al., 2013; Taghian et al., 2014 “Chemotherapy refers to the use of any drug to treat any disease. But to most people, the word chemotherapy (or "chemo") means drugs used for cancer treatment.).Aim of the study: The main purpose of this study will be to examine the effect of Augmented Virtual Reality (AVR) on pain, stress, anxiety, and self-efficacy among adult cancer patients undergoing chemotherapy sessions in the West Bank hospitals in Palestine. Method: The design will be randomized control trial RCT design including a pretest and posttest to find a cause-and-effect association between an independent and dependent variable with 150 participants. . The participants will divided into two groups, the intervention group, which receives augmented virtual reality therapy, and the control group, which receives standard treatment. The study will use a pretest and posttest design to assess the effect of augmented virtual reality therapy on psychological outcomes, including stress, anxiety, pain, and self-efficacy. By comparing the psychological outcomes of the two groups, the study will be able to determine the effect of augmented virtual reality therapy on these outcomes and provide insights into its effectiveness as a therapeutic intervention.
External Link(s)

Registration Citation

Citation
abuliel, farid. 2023. "The Effect of use Augmented Virtual Reality on Pain, Stress, Anxiety, and Self-Efficacy among Adult Cancer Patients undergoing Chemotherapy in the West Bank." AEA RCT Registry. October 04. https://doi.org/10.1257/rct.12172-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
The researcher will assign randomly the patients to the intervention or to the control groups. On the first day of data collection, both groups participants will fill the demographic and the instruments of the study. The study will be conduct in two phases to prevent the contamination between the two groups:
Phase one: the control group will participate in routine session without AVR, patient admitted to the day care unit, canula applied then the nurse follows the doctor order for the type of medication that will be given to the patient then the patients will fill the questionnaire at posttest.
Phase two: the intervention group will receive AVR before they started treatment and during the session. The researcher will be administered posttest questionnaire in exactly same way in pre-test
Intervention Start Date
2023-07-01
Intervention End Date
2023-12-15

Primary Outcomes

Primary Outcomes (end points)
Effect of use Augmented Virtual Reality on Pain, Stress, Anxiety, and Self-Efficacy
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The design will be randomized control trial RCT design including a pretest, and posttest that purposes to find a cause-and-effect association between an independent and dependent variable. The participants are divided into two groups, the intervention group, which receives augmented virtual reality therapy, and the control group, which receives standard treatment. The study will use a pretest and posttest design to assess the effect of augmented virtual reality therapy on psychological outcomes, including stress, anxiety, pain, and self-efficacy. By comparing the psychological outcomes of the two groups, the study will be able to determine the effect of augmented virtual reality therapy on these outcomes and provide insights
Experimental Design Details
Randomization Method
will be done as randomization in office by a compute
Randomization Unit
it will be individual level were participants will be alone with the intervention
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
3 hospital will be involved in the study
Sample size: planned number of observations
150 participants will be 75 interventional 75 will be control
Sample size (or number of clusters) by treatment arms
75 participants
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The sample will be selected by convenience sampling, from cancer patients who are scheduled to receive chemotherapy from the targeted hospitals. The sample size calculated using G. Power 3.1.9.2 software the Second Version. And by using the Power of 0.80, alpha of .05 (Frerk et al., 2015; Kim, Lee, & Na, 2017; Nishiyama, Ito, & Kato, 2014), and a medium effect size 0.5 (Faul, Erdfelder, Lang, & Buchner, 2007) and the calculated sample size was based on independent t test with total of 128 participants. To overcome the attrition rate and who refuse to participate, the final sample will be 150 participants. They will be distributed in two equal groups: 75 as the interventional group and 75 as the control group from all hospitals.
Supporting Documents and Materials

Documents

Document Name
IRB approval litter
Document Type
irb_protocol
Document Description
File
IRB approval litter

MD5: 4ed4b8ad60a4ff7457d15f7278849ec0

SHA1: 2f1e8d55a5baedaab1f5266450dac93c12313dbd

Uploaded At: September 24, 2023

Document Name
ministry of health approval
Document Type
Document Description
File
ministry of health approval

MD5: 4d79ccdec7b120241d73f850848d22d8

SHA1: 9a579fa7c33cf7e69365448e6fd7d1a7ba91a048

Uploaded At: September 24, 2023

IRB

Institutional Review Boards (IRBs)

IRB Name
Arab American University IRB committee
IRB Approval Date
2023-06-16
IRB Approval Number
2023/A/99/N
Analysis Plan

Analysis Plan Documents

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials